Currently Ling serves as the global Chairman and CEO of ClinChoice, a global full-service CRO with over 1800 clinical research professionals in more than 50 cities and 7 countries around the world.
Previously, Ling was a partner at the Draper Dragon Venture Group (a member of the Draper Venture Network), focusing on the investment and management of life science and healthcare companies in China and the US.
Earlier, Ling had spent 12 years in Quintiles (the largest clinical CRO in the world and later merged with IMS Health to form the world leading human data science company called IQVIA), where he served as a global Senior Vice President and the General Manager in Greater China (including China, Hong Kong and Taiwan), to oversee clinical operation, data and consulting service in the region.
Prior to Quintiles, Ling also served as a management consultant in the Life Science Strategy Group of Ernst & Young in the US, where he advised leading pharmaceutical and biotech companies on mission-critical strategic and operational issues. In addition, Ling held various leadership positions in Business Development and Portfolio Management in some of the world-leading life science companies such as Eli Lilly and GlaxoSmithKline in the US.
Ling received his Bachelor of Science degree from the University of Science and Technology of China，his Master of Science degree in biochemistry and Master of Business Administration degree from Indiana University at Bloomington in the US. Ling also holds a Juris Doctor degree from the Law School of North Carolina Central University and is a licensed attorney in the state of North Carolina in the US.
Xin Ke, PhD, is the Chairman and Co-founder of ClinChoice Inc. Dr. Ke has over 20 years of experience in the pharmaceutical industry, with a focus on data management and statistical programming.
Since 1992, he has worked for several global pharmaceutical companies, including Novartis, Johnson & Johnson, and Merck, as a senior statistical analyst. In 1995, he founded K&L Consulting Services, Inc. (K&L), which provides niche contract research organization (CRO) services to global pharmaceutical and biotech companies in the areas of data management, biostatistics, biostatistical programming, CDISC/SDTM/ADaM standardization and conversion, and medical writing. In 2014, K&L merged with Fountain Medical Development, Ltd. (FMD, China), to become FMD K&L. In 2016, FMD K&L merged with iMEDGlobal, further expanding services and global geographic presence.
Since founding K&L, Dr. Ke has acted as a project team lead for several pharmaceutical companies, supporting 15 US NDA filings. The filings were well accepted by FDA and 11 have been approved for marketing.
Dr. Ke received his PhD from Rutgers University and BS in Applied Mathematics from Tsinghua University, China.
John D. Balian, MD, is the Chief Executive Officer of ClinChoice Inc. In February 2016, he founded the consulting firm MediVista, focusing on development of healthcare and IT companies and transformative technologies. Previously, he was a senior executive at Johnson & Johnson, where he served as Chief Medical Officer of the Johnson & Johnson Family of Consumer Companies, leading Medical, Clinical, Regulatory, Medical Safety, Toxicology, and related functions. In April 2014, Regional R&D was added to his remit and his title became Chief R&D Operations Officer.
Dr. Balian joined Johnson & Johnson from Pfizer Inc, where he was Senior Vice President, Worldwide Safety & Regulatory Operations. He led efforts to capitalize on the immense data streams Pfizer collects to gain new insights into patient needs and find new opportunities to serve them better. He launched and successfully executed a complete transformation of the organization’s structure, practices and strategies to address performance and regulatory challenges facing the company.
In 10 years at Pfizer, Dr. Balian held numerous leadership positions, originally joining as an Associate Director in Drug Safety before soon becoming Vice President and Global Head for Clinical Safety and Risk Management. In 2003, he was appointed VP in Development Operations, leading a multi-functional organization responsible for Pfizer’s sourcing strategies, capacity planning, clinical trials conduct and allocation, patient recruitment, performance measures and business/operational support for all clinical trials.
He also served at Bristol-Myers Squibb, leading the Global Pharmacovigilance & Epidemiology group and a Medical Affairs group focusing on mature brands. Among the many innovative methodologies he introduced was a BMS global operations center for pharmacovigilance in Chennai, India, an industry first.
Previously, Dr. Balian worked for the U.S. Food & Drug Administration, first as a Medical Reviewer for neuropharmacology products, and then as an Associate Director in the Office of Clinical Pharmacology and Biopharmaceutics. Widely published in scientific journals, he is also a published novelist. He earned his B.A. degree from Columbia University and his M.D. degree from Tufts University School of Medicine.
Tiepu Liu, MD, PhD, is President of Global Biometrics at ClinChoice. He plans goals and strategies and manages organizational structure and operational standards and process. He leads experienced clinical development teams specialized in data management, biostatistics, and programming to provide high quality and timely services to global biopharmaceutical clients.
Dr. Liu served as a Biostatistician and Epidemiologist at the UAB Comprehensive Cancer Center and led a Biostatistics and Epidemiology group at the University of Cincinnati. In his industry career, he has served as Director of Biostatistics at PPD, Executive Director of Statistics and Data Management at UBC, and Senior Director of Biostatistics at Graceway Pharmaceuticals and The Medicines Company.
Dr. Liu has published over 100 scientific papers. He has worked with numerous Data Monitoring Committees (DMCs) in various capacities, including serving as a voting statistician member and coordinating and presenting frequently to DMCs. Dr. Liu has led numerous clinical development programs in various therapeutic areas. He served as core lead in gaining global approval and successful commercialization of Arestin (minocycline), Zyclara (imiquimod), and Kengreal (cangrelor) interacting with various regulatory agencies, including FDA, EMA, PMDA, and NMPA.
Dr. Liu received his doctoral degree in Biostatistics and Epidemiology from the University of Alabama at Birmingham (UAB) after completing Medical and Public Health training at Tongji Medical University, China.
A co-founder of iMEDGlobal (a ClinChoice Company), Mahesh has more than 27 years of industry experience including 14 years of designing and implementing global software solutions in the healthcare and pharmaceutical domains.
His most recent experience includes tenures as CEO iMEDGlobal Inc – a KPO company providing services in the life sciences space. He was instrumental in taking the company from inception to a 500+ member strong company. He was also the Global Head, Product Development at ArisGlobal, India, and Engineering Manager at WYSE, India. He has also worked as a consultant, with DSA to help develop its IT service offering for the life sciences industry and worked on the Triage XML Intake system. Prior to the Life Sciences space, Mahesh has worked extensively in the Banking and Enterprise domain designing and developing solutions.
Mahesh has a bachelor’s degree in Instrumentation Engineering from Bangalore University, India
Yuguang Zhao is the Senior Vice President of Global Programming and Development. Mr. Zhao provides scientific direction, strategic planning, and resource arrangement for statistical programming development and support on all projects, ensures high quality and timely delivering.
Mr. Zhao has over 24 years of experiences in providing statistical programming for Phase I through Phase IV clinical trial studies in the pharmaceutical industry. Prior to joining ClinChoice, Mr. Zhao was Director of Global Statistical Analysis at Eisai Pharmaceuticals, and served as Programming Therapeutic Area Head for Oncology at Sanofi. In these roles, he led multidisciplinary teams and worked on numerous regulatory submissions such as NDAs/sNDAs. Mr. Zhao has co‐led the CDISC/FDA data integration pilot, and has been a key contributor in the industry standardization efforts through his participation in CDISC SDS and ADaM working groups.
Mr. Zhao earned his MS from the University of Nevada and his BS from Inner Mongolia National University, China.
Lee King is the SVP of Business Development and Marketing at ClinChoice Inc. In this role, Mr. King is responsible for overseeing Business Development, Marketing, and Proposal Development groups.
Mr. King has more than 25 years of experience in clinical research encompassing all phases of development and commercialization in drugs, vaccines, and medical devices. Before joining ClinChoice, Mr. King was the Global Head of Business Development and Strategy at CPi Global CRO. He also served as the Global Head of Peri/Post Approval and Clinical Outcomes Assessments at ICON. Prior to ICON, Mr. King held various senior roles at PPD, both in Hematology/Oncology and Late Phase Development. His strong portfolio of business development and therapeutic experiences enables him to help sponsors with their strategic development planning, commercialization, and resource optimization.
Mr. King has a BA from The University of North Carolina at Wilmington, a master’s degree in education from East Carolina University, and a professional certificate in international business from University College Dublin.
Lei Lu, MS, MBA, is the Vice President of Business Operations at ClinChoice Inc. She provides leadership for strategies and processes and oversees activities in business operations, including contract, legal, human resources, and day-to-day administration.
Ms. Lu has over 28 years of combined experience in the biotechnology, pharmaceutical, and CRO industries. Prior to joining ClinChoice, she worked at Merck for 20 years in diverse areas ranging from quality to RR&D to global business procurement. Her broad experience allows her to provide oversight of business operations and think strategically with her deep understanding of the technical and business aspects of the pharmaceutical industry.
Ms. Lu has an MBA in finance from Temple University, an MS in Organic Chemistry from Texas Women’s University, and a BS in Chemistry from Sichuan University in China.
Dr. Vanita Srinivasan is the Vice President, Global Safety and Medical Affairs at ClinChoice. She has over 18 years of healthcare experience supporting pharmaceutical, medical device, and consumer healthcare innovators. At ClinChoice, Dr. Srinivasan manages operations across all the delivery centers, leading teams for several large-, mid-, and small-sized clients. Under her leadership, we seamlessly deliver on-time, quality solutions for all our clients.
Dr. Vanita has helped pharmaceutical clients manage their clinical and post-marketing safety initiatives during her time in Accenture and IQVIA. She leverages her hands-on experience as a physician, medical writer, and Delivery Head for large case processing operations to give direction for ClinChoice’s growth. As a safety subject matter expert, Dr. Vanita designs solutions for pharmacovigilance and device safety and consults to set up global safety operations. Her expertise and leadership style has led to several collaborative engagements with our clients.
She holds a medical degree, is a post-graduate in Clinical Research from Cranfield University, and has an MBA from XLRI. She is a CQI IRCA certified ISO 9001:2015 Lead Auditor and trained on Implementation of MDR (BSI).
Jayme Calhoun is the Senior Director of Regulatory Affairs for ClinChoice. In this role she oversees the North American arm of ClinChoice’s Regulatory Centers of Excellence to deliver comprehensive regulatory support to clients. Jayme has over 20 years of industry experience spanning from Novel Drugs to Consumer products, with a focus on Medical Device regulations.
Previously, Jayme was Vice President of Regulatory Affairs at a start-up biotechnology company where she created and grew a new regulatory department for initial applications and market expansion of devices, combination products, drugs, and consumer products. Prior to that, she was a Project Manager for a tissue based BLA project overseeing the timely completion of cGMP upgrades and Phase III clinical trials.
Earlier, Jayme spent 8 years with Surgical Specialties in Quality and Regulatory roles overseeing corporate regulatory and quality goals for 3 manufacturing facilities, and acting as a regulatory liaison for FDA, Notified Bodies, and PMDA audits. Her prior experience includes roles at Medtronic and GlaxoSmithKline. In addition to serving as a management representative for multiple Heath Authority audits, she has experience supporting international registrations, authoring FDA, Health Canada, and EU submissions, and is respected for her ability to work with regulators from both a quality and regulatory aspect.
Jayme received her Bachelor degree in Chemistry from Connecticut College and her Master of Business Administration degree from the University of Florida. Jayme holds a RAC certification in Medical Devices.
Dr. Seda Aghabekyan is the Head of Clinical Operations and Safety, Armenia. Since 2015, Seda has worked in the ClinChoice Armenia delivery center, contributing to clinical development strategy, medical affairs, and safety projects, providing medical safety oversight and consultation for medical scientific research and literature surveillance projects. Building, coordinating, leading teams, Dr. Aghabekyan enhances operations in a globally dispersed team environment with cross-cultural partners by developing professional relationships and communicating with industry leaders.
Dr. Seda Aghabekyan, MD, MPH, is a Research Physician with 11 years of clinical development experience, including six years of global medical and clinical leadership experience.
Seda graduated from Yerevan State Medical University with an MD Physician and Radiologist specialization. Her Master of Public Health Degree was completed at the American University of Armenia, Turpanjian School of Public Health (SPH).
Zaruhi Tovmasyan, M.Sc. Biology, is the Head of Regulatory Affairs of Armenia unit since 2016. Zaruhi has more than 12 years of experience in regulatory affairs and has spent several years working as the local pharmacovigilance contact.
Zaruhi has been involved in different projects related to other areas of drug and medical device circulation such as importation and distribution of drugs, medical devices, cosmetics, medical writing, protection of intellectual property, registration of trademarks, implementation of good distribution practice, site preparation for external and internal audits, as well as for inspection by regulatory authorities.
Zaruhi has led numerous projects in Armenia and other CIS countries, including Georgia. She has extensive experience working with various divisions of health authorities of the countries mentioned above.
Zaruhi has been an active member in several professional groups for many years, focusing on technical, CMC, quality, and regulatory topics. She earned her master’s degree in biology from Yerevan State University.
Connie Andrews is the Vice President of Clinical Operations for ClinChoice. In this role, she leads ClinChoice’s Clinical Operations to deliver quality and superior service to our clients. Connie has over 30 years of industry clinical operations experience spanning from large pharma, Biotech and CRO’s large and mid-sized. Connie has been responsible for Project Management, Monitoring, Outsourcing and Strategic Partnerships, Clinical Supplies, Medical Writing, Data Management, Biometrics and Training globally. In addition, she has experience with acquisitions and integration.
Over the years, Connie has developed processes to decrease costs, increase efficiency and quality. She is an experienced executive coach aimed at developing staff for senior/executive positions as well as increasing personnel effectiveness. Connie received her Bachelor’s degree in Psychology from United States International University and her Master’s degree in Psychology from National University. Connie is a US Navy veteran.